A Study of Lebrikizumab in Participants With Uncontrolled Asthma on Inhaled Corticosteroids and a Second Controller Medication

Completed · Phase 3 · Has a placebo group

Conditions studied: Asthma

In brief

This randomized, multicenter, double-blind, placebo-controlled, parallel-group study will evaluate the efficacy and safety of lebrikizumab in participants with asthma whose disease remains uncontrolled despite daily treatment with inhaled corticosteroid (ICS) therapy and at least one second controller medication. Participants will be randomized in 1:1:1 ratio to receive double-blind treatment with either lebrikizumab ("high" or "low") or placebo, administered as subcutaneous (SC) injection every 4 weeks for 52 weeks, in addition to their standard-of-care therapy. This will be followed by a 52-week double-blind active treatment extension. Participants who were assigned to placebo during the placebo-controlled period of the trial will be re-randomized at Week 52 to receive blinded SC lebrikizumab 37.5 milligrams (mg) or 125 mg every 4 weeks from Weeks 53 to 104. The anticipated time on study treatment is 104 weeks. After study treatment, all participants will complete a 20-week safety follow-up.

Key facts

Study ID: NCT01868061
Run by: Hoffmann-La Roche
People needed: 1068
Starts: 2013-07-31
Expected to finish: 2017-01-02
Last updated by the study team: 2017-05-19

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Asthma diagnosis for greater than equal to (>/=) 12 months at Visit 1
Bronchodilator response at Visit 1, 2, or 3
Pre-bronchodilator FEV1 of 40 percent (%) - 80% predicted at both Visits 2 and 3
On ICS therapy at a total daily dose of 500-2000 microgram (mcg) of fluticasone propionate dry powder inhaler (DPI) or equivalent for >/= 6 months prior to Visit 1
On an eligible second controller medication (long-acting Beta-agonist [LABA], leukotriene receptor antagonist [LTRA], long-acting muscarinic antagonist [LAMA], or theophylline) for 6 months prior to Visit 1
Uncontrolled asthma at Visit 1 and/or Visit 2, and at Visit 3
Chest X-ray or computed tomography (CT) scan within 3 months prior to Visit 1 or chest X-ray during the screening period (prior to Visit 3) confirming the absence of other clinically significant lung disease
Demonstrated adherence with controller medication during the screening period

You may not qualify if…

History of severe allergic reaction or anaphylactic reaction to a biologic agent or known hypersensitivity to any component of the lebrikizumab injection
Maintenance oral corticosteroid therapy within 3 months of Visit 1
Treatment with systemic (oral, intravenous [IV], or intramuscular [IM]) corticosteroids within 4 weeks prior to Visit 1 or during the screening period
Treatment with intra-articular corticosteroids within 4 weeks prior to Visit 1 or during the screening period or anticipated need for intra-articular corticosteroids during the course of the study
Infection requiring hospital admission for >/=24 hours or requiring treatment with IV or IM antibiotics within 4 weeks prior to Visit 1 or during screening; Upper or lower respiratory tract infection within 4 weeks prior to Visit 1 or during screening; Active parasitic infection or Listeria monocytogenes infection within 6 months prior to Visit 1 or during screening
Active tuberculosis requiring treatment within 12 months prior to Visit 1
Known immunodeficiency, including, but not limited to, human immunodeficiency virus (HIV) infection
Evidence of acute or chronic hepatitis or known liver cirrhosis
History of interstitial lung disease, chronic obstructive pulmonary disease (COPD), or other clinically significant lung disease other than asthma
Known current malignancy or current evaluation for potential malignancy
Current smoker or former smoker with a history of greater than (>) 10 pack-years
History of alcohol or drug abuse
Past and/or current use of any anti-interleukin (IL)-13 or anti-IL-4/IL-13 therapy, including lebrikizumab; use of other monoclonal antibody therapy, including omalizumab, within 6 months or 5 drug half-lives prior to Visit 1 (whichever is longer) or during screening
Initiation of or change in allergen immunotherapy within 3 months prior to Visit 1 or during screening

Where it is running

Medical Research of Arizona; Allergy, Asthma & Immu — Scottsdale, Arizona, United States
Quality of Life Medical & Research Center — Tucson, Arizona, United States
Kern Allergy Med Clinic, Inc. — Bakersfield, California, United States
Allergy and Asthma Relief Experts — Granada Hills, California, United States
Southern California Institute For Respiratory — Los Angeles, California, United States
Allergy & Asthma Consultants — Redwood City, California, United States
Integrated Research Group Inc — Upland, California, United States
Allergy & Asthma Medical Group; Clinical Research Division — Walnut Creek, California, United States
Asthma & Allergy; Associates, P.C. — Colorado Springs, Colorado, United States
Storms Clinical Research; Institute — Colorado Springs, Colorado, United States
National Jewish Health — Denver, Colorado, United States
Colorado Allergy & Asthma Centers, Pc — Denver, Colorado, United States
Western States Clinical Research, Inc — Wheat Ridge, Colorado, United States
Yale University School Of Medicine — New Haven, Connecticut, United States
Allergy Consultants PA — Boca Raton, Florida, United States
Research Institute of South Florida Inc — Miami, Florida, United States
Sarasota Clinical Research — Sarasota, Florida, United States
Georgia Pollens — Albany, Georgia, United States
Brookstone Clinical Res Ctr — Columbus, Georgia, United States
Southeast Regional Research Group — Columbus, Georgia, United States
DataQuest Medical Research — Lawrenceville, Georgia, United States
Aeroallergy Research Labs — Savannah, Georgia, United States
Atlanta Allergy & Asthma Clini — Woodstock, Georgia, United States
East-West Medical Research Institute — Honolulu, Hawaii, United States
Clinical Research Center of Alabama, LLC — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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